FDA.reportPublic FDA data

0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe

RxCUI
829987
RxNorm name
0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe
Display name
0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe
Full name
0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103907PediarixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b63c4c7d-3dbf-419d-84cc-2c1957b92be70.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled SyringeSCD30These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
b63c4c7d-3dbf-419d-84cc-2c1957b92be7diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled SyringeSY30These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
b63c4c7d-3dbf-419d-84cc-2c1957b92be7DTaP-HepB-IPV 0.5 ML Prefilled SyringeSY30These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
b63c4c7d-3dbf-419d-84cc-2c1957b92be7acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled SyringeSY30These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
b63c4c7d-3dbf-419d-84cc-2c1957b92be7DTaP-HepB-IPV 0.5 ML Prefilled SyringePSN30These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] injectable suspension, for intramuscular use Initial U.S. Approval: 200220260514
dd047022-e51c-4aa1-bd68-bc23161c3ce3DTaP-HepB-IPV 0.5 ML Prefilled SyringePSN2These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813
dd047022-e51c-4aa1-bd68-bc23161c3ce3acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled SyringeSY2These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813
dd047022-e51c-4aa1-bd68-bc23161c3ce3DTaP-HepB-IPV 0.5 ML Prefilled SyringeSY2These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813
dd047022-e51c-4aa1-bd68-bc23161c3ce30.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled SyringeSCD2These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813
dd047022-e51c-4aa1-bd68-bc23161c3ce3diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled SyringeSY2These highlights do not include all the information needed to use PEDIARIX safely and effectively. See full prescribing information for PEDIARIX. PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 200220250813